Volumetric Monitoring in Major Lung Surgery (EVLW-PNEUMO)

September 4, 2012 updated by: Vsevolod V. Kuzkov, Northern State Medical University

Pulmonary Edema Following Major Thoracic Resections: a Value of Perioperative Volumetric Monitoring

The hypothesis of this observational single-center clinical study was to explore the volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic intervention. The investigators monitored the changes in the volumes of blood in the central vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e. extravascular lung water).

Study Overview

Status

Completed

Conditions

Detailed Description

The goal of this observational study is to investigate into changes in volumetric hemodynamic parameters obtained with a technique of transpulmonary indicator dilution after major thoracic intervention, including pneumonectomy and lobar resections. The important parameters of hemodynamics were monitored throughout the intervention and 48 hrs postoperatively, including extravascular lung water index, global end-diastolic volume index, etc.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Arkhangelsk Region
      • Arkhangelsk, Arkhangelsk Region, Russian Federation, 163000
        • Regional Hospital of Arkhangelsk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population includes the patients scheduled for extended thoracic resections (lobar resection and pneumonectomy) due to bronchial cancer or severe destructive pulmonary infection (abscess and/or pneumonia).

Description

Inclusion Criteria:

  • Informed consent
  • Age above 18 and below 80
  • Confirmed malignant bronchial neoplasm or
  • Destructive pulmonary infection

Exclusion Criteria:

  • Pregnant
  • Severe pulmonary hypertension
  • Pulmonary tuberculosis
  • Severe occlusive atherosclerosis of lower extremities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern State Medical University

Collaborators

University of Tromso
Regional hospital of Arkhangelsk

Investigators

  • Principal Investigator: Vsevolod V. Kuzkov, MD, PhD, Northern State Medical University
  • Principal Investigator: Mikhail M. Orlov, MD, Regional Hospital of Arkhangelsk
  • Study Chair: Mikhail Y. Kirov, MD, PhD, Northern State Medical University
  • Study Director: Lars J. Bjertnaes, MD, PhD, University of Trmsoe, Tromsoe, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 17, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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